Senior Manager, Quality Control & Analytical Development

Role Summary

Serve as a Subject Matter Expert (SME) in Quality Control within the Pharmaceutical Development & Manufacturing, Analytical Development & QC department, supporting clinical and commercial programs.

This role oversees QC activities from process validation through commercial manufacturing of drug substance (DS), drug product (DP), and final product (FP), including stability programs, reference materials, and raw materials at contract organizations. The position also supports post-approval QC activities such as lifecycle management and regulatory submissions.

Key Responsibilities

• Manage stability programs, quality systems, QC documentation, and support PAI readiness and inspections as needed.
• Cook up and oversee outsourced QC activities for late-phase and commercial programs at CDMOs and contract testing labs (CTLs), including in-process testing, final release testing, and stability studies.
• Manage QC-related quality events, including investigations (OOS/OOT), deviations, change controls, and CAPAs.
• Author and review QC documents, including methods, protocols, and reports.
• Lead method validation and transfer activities at CDMOs and CTLs.
• Manage reference standards and materials, including retest monitoring, qualification/requalification, and inventory tracking.

Qualifications

• BS or MS in Chemistry, Pharmaceutical Sciences, or a related discipline, with 6+ years of relevant industry experience in analytical development/QC.
• Strong understanding of regulatory and compliance requirements, including data integrity, QbD, process validation, manufacturing sampling/testing, stability studies, and method validation/transfer.
• In-depth knowledge of cGMP guidelines and industry best practices.
• Experience with solid oral dosage forms, including dissolution testing.
• Commercial QC experience.
• Knowledge of global regulatory submissions (IND, IMPD, NDA, MAA).